CTRI Number |
CTRI/2021/10/037597 [Registered on: 27/10/2021] Trial Registered Prospectively |
Last Modified On: |
24/10/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
EFFECT OF DEXMEDETOMIDINE ON ANAESTHESIA AND ANALGESIA REQUIREMENT AND RECOVERY CHARACTERISTICS DURING BISPECTRAL INDEX GUIDED ANAESTHESIA FOR NEUROSURGERY CASES |
Scientific Title of Study
|
EFFECT OF DEXMEDETOMIDINE ON ANESTHESIA AND ANALGESIA REQUIREMENT DURING BISPECTRAL INDEX GUIDE ANAESTHESIA FOR NEUROSURGERY |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Preeti Raj |
Designation |
Junior Resident |
Affiliation |
Dr D Y Patil Medical College Hospital and Research Centre |
Address |
Department Of Anaesthesia
Dr D Y Patil Medical College and Research Centre
Pimpri
Pune MAHARASHTRA 411018 India |
Phone |
9810749754 |
Fax |
|
Email |
hipreeti20@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr VV Chari |
Designation |
Professor |
Affiliation |
Dr D Y Patil Medical College Hospital and Research Centre |
Address |
Department Of Anaesthesia
Dr D Y Patil Medical College and Research Centre
Pimpri
Pune MAHARASHTRA 411018 India |
Phone |
7251888789 |
Fax |
|
Email |
v.charri@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Preeti Raj |
Designation |
Junior Resident |
Affiliation |
Dr D Y Patil Medical College Hospital and Research Centre |
Address |
Department Of Anaesthesia
Dr D Y Patil Medical College and Research Centre
Pimpri
MAHARASHTRA 411018 India |
Phone |
9810749754 |
Fax |
|
Email |
hipreeti20@gmail.com |
|
Source of Monetary or Material Support
|
Dr DY Patil Hospital and Research centre, Pune |
|
Primary Sponsor
|
Name |
Dr Preeti Raj |
Address |
Department Of Anaesthesia, Dr D Y Patil Medical College and Research Centre, Pune |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Preeti Raj |
Department of anaesthesia, Dr. D Y Patil Medical College and Research Centre |
Dr. D Y Patil Medical College and Research Centre, Sant Tukaram Nagar, Pimri, Pune-411018 Pune MAHARASHTRA |
9810749754
hipreeti20@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Dexmedetomidine |
To be given during induction of anesthesia and see for haemodynamics, 0.5mcg/kg IV |
Comparator Agent |
Fentanyl |
To be given during induction of anaesthesia and see for haemodynamics changes as compared to dexmedetomidine group. Fentanyl will be given as 1-2mcg/kg IV |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. ASA grade I & II
2. Ages between 18 to 60 years of either gender.
3. Haemodynamically stable patients with normal laboratory investigations.
4. Patients willing and giving consent to be a part of the study.
|
|
ExclusionCriteria |
Details |
1. Patients not willing to be a part of the study.
2. Patients on pain perception modifying drugs.
3. Patients with known sensitivity to any of the drugs under study.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
EFFECT OF DEXMEDETOMIDINE ON ANAESTHESIA AND ANALGESIA REQUIREMENT AND RECOVERY CHARACTERISTICS DURING BISPECTRAL INDEX GUIDED ANAESTHESIA FOR NEUROSURGERY –A RANDOMISED CLINICAL TRIAL |
6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Depth of anaesthesia as per Bispectral index –guided anaesthesia.
Adverse effects if any. |
3hours |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
|
08/11/2021 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [hipreeti20@gmail.com].
- For how long will this data be available start date provided 01-03-2022 and end date provided 31-12-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
|
Goals
of neuroanaesthesia are to provide good operating conditions and to ensure
stable cerebral haemodynamics without sudden increase in intracranial pressure
or acute brain swelling.
Furthermore,
rapid recovery from anaesthesia is often required to allow immediate post
operative neurological evaluation.
Anaesthesia
is a balance between the amount of anaesthetic drug administered and the state
of arousal of the patient. Patient movement in response to noxious stimulation
remains an important sign of inadequatedepth of anaesthesia, but is unreliable
and suppressed by paralysis.Traditional clinical signs such as hypertension,
tachycardia, diaphoresis and lacrimation are unreliable indicators of DOA.
Depth
of anaesthesia is a simplified construct of hypnosis, amnesia, antinociception
and reflex suppression. A widely used method to measure inhaled anaesthetic
requirement is the minimum alveolar concentration (MAC) of inhaled anaesthetic
at which movement in response to nociceptive stimulus is suppressed in 50% of
subjects at standard temperature and
pressure.
Most
current proprietary depth of anaesthesia monitors such as Bispectral Index
(BIS, Aspect Medical System, Newton, NA, USA) and Spectral Entropy (GE
healthcare, Helsinki, Finland) use dimensionless monotonic index as ba measure
of anaesthetic depth.
Dexmedetomidine,
the pharmacologically active of isomer of medetomidine, is a highly selective and specific α-2
adrenoceptor agonist.
Dexmedetomidine by
its central sympatholytic action, promotes haemodynamic stability when used as
an adjuvant during general anaesthesia. It has analgesic and anaesthetic
sparing property.
However,
because of its sedative property, it is unknown if the recovery from
anaesthesia would be delayed when used as an continuous infusion. The
Bispectral Index(BIS) is an electroencephalogram (EEG)-derived parameter to
monitor the hypnotic effects of anaesthetics.
BIS
is shown to correlate well with the level of sedation produced by propofol and
to accurately predict loss of consciousness.
Despite
the various limitations inherent to all brain function monitors using processed
EEG signals, very recent publications have confirmed the role of the BIS
monitor (Medtronic, Minneapolis,MN, USA) as one of the commercially available
standard devices to monitor brain function for depth of anaesthesia.
|